AUTHORIZATION CONDITIONS RELEVANT FOR CERTAIN STEPS OF THE AUTHORIZATION PROCESS FOR
COMPLEX FACILITIES OR ACTIVITIES
II.1. In addition to general authorization conditions that are applicable to all authorizations, there are some specific conditions that are relevant only at certain steps of the authorization process. The following list of conditions is not all-inclusive, nor is it the only possible arrangement, but it may be helpful in determining which conditions are relevant.
SITE PREPARATION
II.2. The regulatory body should specify the controls that the authorized party is required to exercise over the use of the site and the degree to which the authorized party may prepare the site without conducting activities which, under the laws and regulations of the State, require an authorization for construction.
CONSTRUCTION
II.3. In authorizing construction, the regulatory body should ensure that certain conditions are fulfilled so that this step can proceed in a manner that ensures safe operation of the facility. These conditions include the following:
(a) The facility should be designed and constructed in accordance with the relevant site parameters approved by the regulatory body.
(b) The facility should be constructed in accordance with the design that has been justified in a safety case. The authorized party should not deviate from this design in any way that might affect safety without following a modification process that requires categorization of the modification according to safety significance. This modification process may require approval or agreement from the regulatory body depending upon the safety significance of the modification.
(c) The authorized party should initiate a radiological study of the region, including an appropriate baseline survey, prior to the start of operation.
(d) The authorized party should prepare reports during the stages of site evaluation and construction to keep the regulatory body informed of the
progress of the project, covering the progress of site studies, the progress of construction and results of the pre-operational environmental monitoring programme.
(e) The authorized party should keep records of site evaluation and construction of the facility (as appropriate), such as the results of site evaluation studies (geological, meteorological and hydrological data, as well as results of the pre-operational environmental monitoring programme), design records, manufacturing records (including results from quality control activities) and erection records (including quality control results and as-built design records). Such records may be useful later in the investigation of events or generic problems and in decommissioning.
II.4. Furthermore, at the time of authorizing construction, conditions may be imposed on the authorized party requiring that it obtain from the regulatory body additional approvals relating to the design of certain parts of the facility.
COMMISSIONING
II.5. In authorizing the commissioning of a facility, the regulatory body should specify a number of conditions, including the following:
(a) Commissioning should be carried out in accordance with a programme approved by the regulatory body.
(b) Completed structures, systems and components important to safety should be put into service only once they have been inspected, tested and approved as being in accordance with the terms of the authorization.
(c) Commissioning records, including records of equipment and system tests, test procedures and test results should be kept to demonstrate to the regulatory body the continuing safety of the facility. Commissioning records should cover the following:
— The results of the commissioning tests and their evaluations;
— Operational data, including data on the facility’s output and performance;
— Modifications performed;
— Results of the radiation protection programme;
— Results of the environmental monitoring programme;
— Radioactive waste management.
(d) The authorized party should provide approved storage facilities for nuclear or radioactive materials. The competent authority responsible for nuclear
security may require that appropriate nuclear security measures be in effect before nuclear or other radioactive material is brought into the facility.
(e) Fissile material or other radioactive material should not be brought onto the site without a regulatory authorization.
(f) From the introduction of radioactive material into the facility, the authorized party should operate the facility only under the control and supervision of authorized personnel using written procedures, in accordance with the operational limits and conditions approved by the regulatory body. Any changes made to the operational limits and conditions should be approved by the regulatory body prior to their implementation.
(g) The authorized party should have an approved emergency plan, coordinated with the other authorities involved in emergency preparedness and response.
OPERATION
II.6. In authorizing operation, the conditions imposed for commissioning should be amended appropriately in the light of commissioning results. The regulatory body should add conditions to the authorization, as necessary, such as the following:
(a) The authorized party should not operate the facility or conduct the activity outside the limits authorized by the regulatory body.
(b) The authorized party should have a procedure for modifications to be approved by the regulatory body in order to ensure that no part of the approved facility that is important to safety will be modified without the prior approval of the regulatory body.
(c) The authorized party should ensure that the facility is subjected to in-service inspection and testing, to be carried out as specified for structures, systems and components important to safety, in accordance with a schedule approved by the regulatory body.
(d) The authorized party should keep operational records to be used in the regulatory oversight for possible examination by the regulatory body.
Operational records should cover:
— Operational data and performance records of the facility or activity;
— Operating log books;
— Inventories of fissile material and other radioactive material;
— Periodic calibration of equipment;
— Periodic testing of equipment and systems;
— Internal reviews or inspections;
— Preventive maintenance and repairs;
— Personnel training;
— Monitoring of occupational exposures;
— Records of workplace monitoring for the facility or activity;
— Radioactive waste management;
— Effluent discharges and the environmental monitoring programme;
— Anticipated operational occurrences and accidents.
(e) The authorized party should ensure that the maintenance of equipment and systems important to safety is carried out in accordance with a schedule approved by the regulatory body.
(f) Only changes given prior approval by the regulatory body should be made to the approved arrangements, schedules, procedures and rules.
(g) The authorized party should ensure that the facility is operated or the activity is carried out only under the control and supervision of authorized personnel in adequate numbers that are acceptable to the regulatory body.
II.7. Authorization conditions relating to liability of the authorized party in the event of an accident are outside the scope of this Safety Guide.
DECOMMISSIONING
II.8. In authorizing the decommissioning of a facility, the regulatory body should take particular care in specifying conditions, since the sanctions of shutting down the facility or revoking the authorization are unlikely to be effective at this stage. The regulatory body should examine the results of the final radiological survey conducted by the authorized party. The final radiological survey should be conducted after the completion of decommissioning activities to ensure that regulatory requirements are met prior to release of the facility from regulatory control.
CLOSURE
II.9. Following the closure of a radioactive waste disposal facility, continuing institutional control, including environmental monitoring, may be necessary.
Depending on national legislation, conditions may be specified in a post-closure authorization held by the authorized party or responsibilities may be taken by a relevant national authority prior to agreeing to closure of the facility.
Appendix III
TOPICS TO BE COVERED BY REVIEW AND ASSESSMENT
III.1. This appendix provides a generic list of topics that should be considered in the review and assessment process by the regulatory body throughout the lifetime of a facility or activity, from site selection to decommissioning or closure. Each topic has been itemized; however, addressing all items does not necessarily mean that every aspect of safety has been fully addressed. Also, depending on the facility or activity and on the particular stage of the lifetime, some topics will be more important than others and the degree of detail necessary in the review and assessment may differ. This Appendix focuses on complex facilities and activities. For less complex facilities and activities, the review and assessment process should follow a graded approach.
THE PHYSICAL NATURE OF THE FACILITY OR ACTIVITY AND ITS ENVIRONMENT
III.2. The following information on the facility or activity and on the processes conducted should be provided by the authorized party at various stages and used as a basis for review and assessment:
(a) A detailed description of the facility or activity, supported by drawings of the layout, the systems and the equipment;
(b) Information on the functional capability of the facility and the nature of the activity, its systems and major items of equipment (including radiation protection equipment and waste management systems and equipment);
(c) The findings of tests that validate the functional capability of equipment and systems;
(d) The results of inspections of components;
(e) Maintenance records;
(f) A description of the physical condition of structures, systems and components on the basis of inspections or tests;
(g) A description of the support facilities available both on and off the site, including maintenance and repair workshops;
(h) Geological, hydrogeological and meteorological conditions at the site;
(i) A description of off-site characteristics, including population densities, land use, industrial structures and facilities (including pipelines) and transport arrangements (such as airports, roads and railways).
INFRASTRUCTURAL ASPECTS
III.3. Throughout the lifetime of a facility or activity, the authorized party will have to propose and implement arrangements for radioactive waste management.
The regulatory body should review and assess any proposals in the safety case for on-site processing (i.e. pretreatment, treatment and conditioning) and storage of radioactive waste, to ensure that the characteristics of the processed waste and the waste packages are compatible with the national strategy for radioactive waste management, any subsequent waste acceptance requirements and regulatory requirements. Specifically, the regulatory body should satisfy itself that the radioactive waste and waste packages:
(a) Are properly characterized and compatible with the anticipated nature and duration of storage pending disposal;
(b) Can be subjected to regular surveillance;
(c) Can be retrieved for further steps in radioactive waste management.
III.4. Adequate arrangements should be made for the transport of radioactive material, waste and equipment both on and off the site. The regulatory body should review and assess these arrangements and should satisfy itself that all national and regulatory requirements have been met.
SAFETY ANALYSIS
III.5. Throughout the lifetime of the facility or activity, the regulatory body should review and assess the information on the facility or activity provided by the authorized party to determine whether the facility or activity is in compliance with the relevant safety and regulatory requirements, and, in particular, information covering the following:
(a) Specification of the safety standards and design codes used.
(b) A compilation of the safety analyses and their assumptions.
(c) Structures, systems and components important to safety.
(d) Limits and permitted operational states.
(e) Anticipated operational occurrences.
(f) Postulated initiating events for the safety analyses:
— External hazards (e.g. external floods, earthquakes, aircraft crashes, transportation accidents, explosions, external fires and meteorological hazards);
— Internal failures (e.g. mechanical and electrical failures);
— Internal hazards (e.g. internal fires, internal floods and internally generated missiles).
(g) Features, events and processes:
— A list of barriers with their relative contributions;
— A description of how requirements for defence in depth are met;
— Anticipated activities for confirmation of performance.
(h) Analytical methods and computer codes used in the safety analyses and the verification and validation of such codes.
(i) Radioactive releases and radiation exposures in normal operation, anticipated operational occurrences and accident conditions.
(j) The authorized party’s safety criteria for analyses of authorized party actions, common cause failures, cross-link effects, the single failure criterion, redundancy, diversity and separation.
III.6. The impacts of the facility or activity on its surroundings should be assessed. Societal and economic issues, land use issues, technical issues such as detailed considerations of geology and hydrogeology, transport routes for the facility and protection of the environment should be taken into account in such an assessment. Both the anticipated impacts and the consequences of anticipated operational occurrences and accident conditions, which are the subject of safety analysis, should be considered.
THE AUTHORIZED PARTY AND THE MANAGEMENT SYSTEM III.7. At all stages of the facility’s lifetime, the authorized party should be required to demonstrate that:
(a) It will be in control of the facility or activity;
(b) It has resources available to meet its obligations and liabilities in connection with an authorization.
III.8. The authorized party should be required to demonstrate that it has a management system in place, whereby all activities are controlled, so as to provide an assurance that requirements for quality assurance, safety and protection of people and the environment will be met. This will include having operational procedures in place.
III.9. For some facilities (notably waste disposal facilities) this demonstration may need to apply for an extended period, perhaps covering several generations, over which control will need to be maintained.
III.10. The information to be provided by the authorized party to the regulatory body for review and assessment should include:
(a) Details of the organizational structure of the authorized party, showing that it has adequate control over the activities of its own staff and its contractors;
(b) A demonstration of the adequacy of resources in terms of sufficient and appropriately trained and experienced staff, ensuring in-house expertise;
(c) A demonstration of the adequacy of the procedures for controlling changes to the organizational structure and resources;
(d) The specification and documentation of the duties of staff, demonstrating the integration of responsibilities for safety into their duties;
(e) A demonstration of the provision of, or access to, a high level of expertise in safety to carry out safety and engineering analyses and to perform associated audit and review functions;
(f) A demonstration of the adequacy of the provisions for financing of continuing liabilities for nuclear damage and of decommissioning;
(g) Provisions for the use of contractors.
III.11. The authorized party should be required to demonstrate that it has in place:
(a) A mechanism for setting operating targets and safety targets;
(b) A policy that states that the demands of safety take precedence over those of production;
(c) Documented roles and responsibilities for individuals and groups;
(d) Procedures for the control of modifications to the facility;
(e) Procedures for the feedback of operating experience to staff, including experience relating to organizational and management aspects;
(f) Mechanisms for maintaining the configuration of the facility and its documentation;
(g) Formal arrangements for employing and controlling contractors;
(h) Staff training facilities and programmes for initial, refresher and upgrade training, including the use of simulators, where appropriate;
(i) A quality assurance programme and regular quality assurance audits with independent assessors;
(j) A system for ensuring compliance with regulatory requirements;
(k) Comprehensive, readily retrievable and auditable records of baseline information and operational and maintenance history;
(l) Staffing levels for the operation of the facility or conduct of the activity that take account of absences, shift working and overtime restrictions;
(m) Sufficient and qualified staff available and on duty at all times;
(n) Systematic and validated methods for the selection of staff, including testing for aptitude, knowledge and skills;
(o) A systematic approach to fostering leadership and management for safety, including training in safety culture, particularly for managers;
(p) Guidelines on fitness for duty in relation to hours of work, health and use of drugs or alcohol;
(q) Competence requirements for operating, maintenance and technical staff and managers;
(r) A system for consideration of the human–machine interface and its design and for the analysis of information needs and task workload for operators in the control room and at other workstations.
OPERATIONAL PROCEDURES
III.12. The authorized party should be required to demonstrate that the operation of the facility or conduct of the activity is in accordance with the relevant safety objectives and safety and regulatory requirements, and that it has developed or obtained the following:
(a) Formal approval and documentation where required by regulatory body;
(b) A formal system for modification of a procedure;
(c) Understanding and acceptance of the procedures by management and staff;
(d) Verification that the procedures are being followed;
(e) Procedures that are adequate in comparison with international good practices;
(f) Arrangements for regular review and, if necessary, revision of the procedures;
(g) Clear procedures in which principles relating to human factors have been taken into account;
(h) Procedures that comply with the assumptions and findings of the safety analysis and with experience from design and operation;
(i) Adequate emergency operating procedures.
EQUIPMENT QUALIFICATION
III.13. The authorized party should be required to maintain:
(a) A list of equipment covered by the equipment qualification programme, including documentation of the analyses used to derive this list of equipment, and a list of control procedures;
(b) A qualification report and other supporting documents (such as equipment qualification specifications and a qualification plan);
(c) Verification that the installed equipment matches the qualification requirements;
(d) Documentation of procedures to maintain qualification over the lifetime of the installed equipment;
(e) Information on mechanisms for ensuring compliance with these procedures;
(f) Documentation of a maintenance, testing and inspection programme and a procedure for providing feedback to ensure that ageing degradation of qualified equipment remains insignificant;
(g) A list of appropriate corrective actions to maintain equipment qualification;
(h) Information on the physical integrity and functionality of qualified equipment;
(i) Records of all qualification measures taken over the installed lifetime of equipment.
III.14. In the selection of equipment for measurements, the minimum detection limit should be commensurate with the compliance level such that the minimum detection limit is around 10% of the level to be measured for demonstration of compliance.
MANAGEMENT OF AGEING
III.15. The authorized party should be required to establish and maintain a programme for the management of ageing of equipment that includes the following:
(a) Documented methods and criteria for identifying structures, systems and components covered by the ageing management programme;
(b) A list of structures, systems and components covered by the ageing management programme and records that provide information for use in the management of ageing;
(c) An evaluation of and documentation of potential ageing related degradation that may affect the safety functions of structures, systems and components;
(d) Details of the extent of understanding of the dominant mechanisms of ageing for structures, systems and components;
(e) Details of the programme for the timely detection and mitigation of ageing processes and/or ageing effects;
(f) Acceptance criteria and required safety margins for structures, systems and components;
(g) Awareness of the physical condition of structures, systems and components, including actual safety margins.
AUTHORIZED PARTY’S SAFETY PERFORMANCE
III.16. The authorized party should be required to provide details of:
(a) The system used for identifying and classifying safety related events.
(b) The arrangements made for root cause analysis of events, the results and lessons learned and the follow-up measures taken.
(c) Methods for selecting and recording safety related operational data, including data for maintenance, testing and inspection.
(d) Trend analyses of safety related operational data.
(e) Feedback of safety related operational data, including records and reports of incidents including accidents.
(f) Records of radiation doses to persons on the site.
(g) Records of off-site contamination and data from radiation monitoring on the site.
(h) Records of quantities and relevant characteristics of radioactive waste generated and stored at the facility.
(i) Records of the quantities of radioactive effluents discharged.
(j) Analyses of safety performance indicators, such as:
— Frequency of unplanned shutdowns of operation;
— Frequency of selected safety system actuations and demands;
— Frequency of safety system failures;
— Unavailability of safety systems;
— Annual individual and collective occupational radiation doses;
— Trends in causes of failures (operator errors, equipment failures, administrative matters, control matters);
— Backlog of outstanding maintenance tasks;
— Extent of repeat maintenance;
— Extent of corrective maintenance, including repair and replacement;
— Frequency of unplanned operator actions in relation to safety and their success rate;
— Amounts of radioactive waste generated;
— Quantities of radioactive waste in storage.
EXPERIENCE FROM OTHER FACILITIES AND RESEARCH FINDINGS
III.17. The authorized party should be required to provide information to the regulatory body on its arrangements for:
(a) Obtaining and assessing feedback of experience relevant to safety from similar facilities and activities and from other nuclear and non-nuclear facilities and activities, and taking action on the basis of this feedback;
(b) Determining the need for research and development;
(c) Obtaining and assessing the findings of relevant research programmes, and taking action on the basis of these findings.